Recruitment

Recruitment Status
Completed

Inclusion Criteria

Familiar with the cycle ergometer exercise methodology
Written inform consent according to good clinical practice (GCP) and local regulations
Females must test negative for pregnancy
...
Familiar with the cycle ergometer exercise methodology
Written inform consent according to good clinical practice (GCP) and local regulations
Females must test negative for pregnancy
Recreational athletes according to the american college of sports medicine (ACSM) definition
Male and female volunteers between 18 and 40 years old

Exclusion Criteria

Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that any drug that could have influence the trail methodology
Pregnancy and/or lactation
Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills [intrauterine devices (IUDs)]
...
Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that any drug that could have influence the trail methodology
Pregnancy and/or lactation
Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills [intrauterine devices (IUDs)]
Known hypertension
Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
Relevant allergy or known hypersensitivity to the investigational drug or its excipients
Smokers
Alcohol and drug abuse (as defined in Diagnostic and Statistic Manual IV( DSM-IV)) per subject verbal report
Liver and/or renal disease and/or vascular disease
Known hypercholesterolemia (moderate/severe)
Female volunteers taking oral or injectable contraceptives

Summary

Conditions
Healthy
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 40 years
Gender
Both males and females

Inclusion Criteria

Familiar with the cycle ergometer exercise methodology
Written inform consent according to good clinical practice (GCP) and local regulations
Females must test negative for pregnancy
...
Familiar with the cycle ergometer exercise methodology
Written inform consent according to good clinical practice (GCP) and local regulations
Females must test negative for pregnancy
Recreational athletes according to the american college of sports medicine (ACSM) definition
Male and female volunteers between 18 and 40 years old

Exclusion Criteria

Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that any drug that could have influence the trail methodology
Pregnancy and/or lactation
Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills [intrauterine devices (IUDs)]
...
Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that any drug that could have influence the trail methodology
Pregnancy and/or lactation
Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills [intrauterine devices (IUDs)]
Known hypertension
Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
Relevant allergy or known hypersensitivity to the investigational drug or its excipients
Smokers
Alcohol and drug abuse (as defined in Diagnostic and Statistic Manual IV( DSM-IV)) per subject verbal report
Liver and/or renal disease and/or vascular disease
Known hypercholesterolemia (moderate/severe)
Female volunteers taking oral or injectable contraceptives

Tracking Information

NCT #
NCT02182882
Collaborators
Not Provided
Investigators
Not Provided